Trial Outcomes & Findings for Comparing Perclose to Statseal With Perclose in Transcatheter Aortic Valve Replacement Arteriotomy Closure (NCT NCT05637970)
NCT ID: NCT05637970
Last Updated: 2025-02-19
Results Overview
From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
24 hours post procedure (± 1 hour)
Results posted on
2025-02-19
Participant Flow
Participant milestones
| Measure |
Perclose Only
Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held. This will be continued until the patient has no bleeding.
Perclose: Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held.
|
Perclose With Statseal Device
Statseal: Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and manualpressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held. This will be continued until the patient has no bleeding.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
24
|
|
Overall Study
COMPLETED
|
26
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Perclose Only
n=26 Participants
Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held. This will be continued until the patient has no bleeding.
Perclose: Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring.
|
Perclose With Statseal Device
n=24 Participants
Statseal: Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and manualpressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held. This will be continued until the patient has no bleeding.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
79.2 years
STANDARD_DEVIATION 6.8 • n=26 Participants
|
80.0 years
STANDARD_DEVIATION 7.3 • n=24 Participants
|
79.6 years
STANDARD_DEVIATION 7.1 • n=50 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=26 Participants
|
8 Participants
n=24 Participants
|
17 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=26 Participants
|
16 Participants
n=24 Participants
|
33 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
26 participants
n=26 Participants
|
24 participants
n=24 Participants
|
50 participants
n=50 Participants
|
PRIMARY outcome
Timeframe: 24 hours post procedure (± 1 hour)From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication.
Outcome measures
| Measure |
Perclose Only
n=26 Participants
Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held. This will be continued until the patient has no bleeding.
Perclose: Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held.
|
Perclose With Statseal Device
n=24 Participants
Statseal: Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and manualpressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held. This will be continued until the patient has no bleeding.
|
|---|---|---|
|
Time to Hemostasis
|
5.11 minutes
Standard Deviation 4.4
|
4.3 minutes
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: 24 hours post procedure (± 1 hour)Presence of small \<5cm, medium 5-10cm, or large \>10cm hematoma based on physical exam or diagnostic imaging.
Outcome measures
| Measure |
Perclose Only
n=26 Participants
Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held. This will be continued until the patient has no bleeding.
Perclose: Patients will have a PercloseTM device deployed at the arteriotomy. Manual pressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held.
|
Perclose With Statseal Device
n=24 Participants
Statseal: Patients will have a PercloseTM device deployed at the arteriotomy. A Statseal disc will applied and manualpressure will be held for at least five minute, the beginning of which will correspond to time point zero. Patent hemostasis will be documented after device deployment. Any manual compression needed or per protocol under the disgression of the operator will count towards the time to hemostasis. After hemostasis is achieved in the cath lab the patient will be sent to the post-operative area for monitoring. If any additional bleeding is appreciated, manual compression will again be held. If any new bleeding from the puncture site or under the skin the patient will again lay supine and at least 10 minutes of manual pressure will be held. This will be continued until the patient has no bleeding.
|
|---|---|---|
|
Patients With Hematoma
Large >10cm
|
1 Participants
|
1 Participants
|
|
Patients With Hematoma
Small <5cm
|
0 Participants
|
0 Participants
|
|
Patients With Hematoma
Medium 5-10cm
|
0 Participants
|
0 Participants
|
Adverse Events
Perclose Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Perclose With Statseal Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place